BIOLOX DELTA HEAD M Ø36MM
Report
- Report Number
- 3008021110-2018-00110
- Event Type
- Injury
- Date Received
- November 21, 2018
- Date of Event
- October 14, 2018
- Report Date
- May 10, 2018
- Manufacturer
- LIMACORPORATE SPA
- Product Code
- LZO
- PMA / PMN Number
- K141327
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
CHECK OF STERILIZATION CHARTS: THE CHECK OF THE STERILIZATION CHARTS DID NOT SHOW ANY ANOMALY ON: A TOTAL OF (B)(4) BIOLOX DELTA FEMORAL HEADS PLACED ON THE MARKET WITH THE SAME LOT# AND STER.#; A TOTAL OF (B)(4) STEMS PLACED ON THE MARKET WITH THE SAME LOT# AND STER.#; A TOTAL OF (B)(4) ACETABULAR CUP PLACED ON THE MARKET WITH THE SAME LOT# AND STER.#; A TOTAL OF (B)(4) DELTA LINER PLACED ON THE MARKET WITH THE SAME LOT# AND STER.#. BY THE RESULTS OF THE OF THE STERILIZATION CHARTS ANALYSES, WE CAN STATE THAT ALL THE PRODUCTS IMPLANTED ON (B)(6) 2018 HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED WITH THESE LOT/STER.#S. EXPLANTS ANALYSIS: NO EXPLANTS OR PICTURES AVAILABLE FOR FURTHER ANALYSIS. X-RAYS ANALYSIS: X-RAY IMAGES WERE NOT AVAILABLE FOR A CLINICAL EVALUATION. WITH THE ONLY VERY FEW INFO PROVIDED, WE CANNOT GO BACK WITH CERTAINTY TO THE ROOT CAUSE OF THE EVENT REPORTED. ACCORDING TO THE INFO REPORTED, THE INITIAL SURGERY WAS PERFORMED WITH NO CONCERNS AND THE REVISION WAS MOST LIKELY DUE TO THE PATIENT'S MASSIVE OBESITY. BY THE ANALYSIS PERFORMED, THIS SEEMS TO BE A CASE NOT PRODUCT RELATED. PMS DATA: WE ARE AWARE OF A TOTAL OF 11 HIP REVISION SURGERIES INVOLVING A BIOLOX DELTA FEMORAL HEADS DUE TO INFECTION ON A TOTAL OF ABOUT (B)(4) CERAMIC FEMORAL HEADS BELONGING TO THE FAMILY 5010.42.XXX SOLD WW SINCE 2004. THIS GIVES A SPECIFIC LOW REVISION RATE OF (B)(4). NO CORRECTIVE ACTIONS PLANNED FOR THIS CASE. LIMACORPORATE WILL KEEP MONITORED THE MARKET.
HIP REVISION SURGERY DUE TO INFECTION PERFORMED ON THE (B)(6) 2018. PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2018. DURING THE REVISION SURGERY, ONLY THE BIOLOX DELTA HEAD M Ø36MM (CODE #5010.42.362, LOT# 1880093, STER. 1800043) HAS BEEN REPLACED - WITH A SAME SIZE BIOLOX DELTA HEAD - AND THE PATIENT RECEIVED A WASHOUT AND ANTIBIOTIC TREATMENT. THE OTHER COMPONENTS IMPLANTED DURING THE PRIMARY SURGERY WERE THE FOLLOWING: H-MAX S STANDARD FEM. STEM #10 CODE #4250.20.100 LOT #1809377 STER. 1800245. DELTA-TT ACETAB.CUP Ø52 MM CODE #5552.15.520 LOT# 1808174 STER. 1800238. DELTA LINER ØINT 36MM # MEDIUM CODE #5885.42.258 LOT#1881009 STER. 1800249. ACCORDING TO THE INFO RECEIVED, THE OBESITY OF THE PATIENT MAY HAVE BEEN CONTRIBUTED TO THE INFECTION. NO ADDITIONAL INFO RECEIVED ABOUT OTHER STAGES REVISION. EVENT OCCURRED IN AUSTRALIA.
WE CHECKED THE STERILIZATION CHATS OF ALL THE COMPONENTS IMPLANTED DURING PREVIOUS SURGERY: H-MAX S STANDARD FEM. STEM #10, CODE 4250.20.100, 1809377, STER. 1800245. FEM. MODULAR HEAD - M Ø36MM, CODE 5010.42.362, LOT#1880093, STER. 1800043. DELTA-TT ACETAB.CUP Ø52 MM, CODE 5552.15.520, LOT# 1808174, STER. 1800238. DELTA LINER ØINT 36MM # MEDIUM, CODE 5885.42.258, LOT#1881009, STER. 1800249. NO ANOMALY WAS FOUND ON THE STERILIZATION CHARTS OF THE ABOVEMENTIONED COMPONENTS; THUS, WE CAN STATE THAT THEY HAD BEEN CORRECTLY STERILIZED BEFORE BEING PLACED ON THE MARKET. WE WILL SUBMIT A FINAL MDR ONCE THE INVESTIGATION WILL BE CONCLUDED.
REVISION SURGERY DUE TO INFECTION PERFORMED ON (B)(6) 2018. PREVIOUS SURGERY "PERFOMED" ON (B)(6) 2018. DURING THE REVISION SURGERY ONLY THE CERAMIC HEAD (CODE 5010.42.362, LOT# 1880093) HAS BEEN REPLACED. ACCORDING TO THE INFO RECEIVED, THE PATIENT IS VERY OBESE. EVENT HAPPENED IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 936285 | BIOLOX DELTA HEAD M Ø36MM | BIOLOX DELTA HEAD M Ø36MM (LZO JDI KWY KWZ LPH MBL) | LZO | LIMACORPORATE SPA | 5010.42.362 | 1880093 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |